Date: 2016-03-31
Type of information: Initiation of preclinical development
phase:
Announcement:
Company: Corbus Pharmaceuticals (USA - MA)
Product: Resunab™ (6aR,10aR)-3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-6H-Dibenzo(b,d)pyran-9-carboxylic acid
Action
mechanism: cannabinoid receptor agonist. Resunab™ is a novel synthetic oral drug that is a preferential agonist to the CB2 receptor expressed on activated immune cells. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Pre-clinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in pre-clinical models of inflammation and fibrosis. Resunab™ triggers resolution of inflammation by increasing production of "Specialized Pro-resolving Lipid Mediators of Inflammation" and anti-inflammatory mediators, while reducing production of pro-inflammatory mediators and reducing the numbers of immune cells in affected tissues. Resunab™ has direct effects on fibroblasts to halt tissue scarring. In effect, Resunab triggers endogenous pathways to turn "off" chronic inflammation and fibrotic processes, without causing immunosuppression.
Disease: systemic lupus erythematosus
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: * On March 31, 2016, Corbus Pharmaceuticals announced that a protocol amendment has been added to one of the Company's existing Investigational New Drug (IND) Application with the FDA for a Phase 2 clinical trial of Resunab in systemic lupus erythematosus. The amendment was filed on February 25, 2016. The addition of the SLE Phase 2 trial to the existing Resunab IND is an important step towards the initiation of the 100 patient, double-blind, placebo-controlled SLE trial which will be funded by a grant from the National Institutes of Health ("NIH") to the Feinstein Institute for Medical Research ("FIMR"), Manhasset. The Company expects the trial will commence in the first quarter of 2017. * On March 7, 2016, Corbus Pharmaceuticals announced that Resunab™ will be tested for efficacy and safety in a Phase 2 clinical study in systemic lupus erythematosus. The SLE trial has been selected for funding by the NIH Autoimmunity Centers of Excellence (ACE) program, through a grant to the Feinstein Institute for Medical Research (FIMR), Manhasset, NY. Cynthia Aranow M.D. is Principal Investigator on the grant, and Meggan Mackay M.D., M.S. is Principal Investigator for the clinical trial of Resunab in SLE. Both Drs. Aranow and Mackay are Investigators at the Center for Autoimmunity & Musculoskeletal Disease at FIMR and Associate Professors of Molecular Medicine at Hofstra Northwell School of Medicine. The Phase 2 trial will test the efficacy, safety, tolerability and biologic effects of Resunab as a novel, non-immunosuppressive oral treatment to improve signs and symptoms of SLE. The study plans to enroll 100 adult SLE patients with active musculoskeletal disease and will be carried out at approximately 10 sites in the United States. These patients will receive either placebo or three different doses of Resunab daily for 84 days with 28 days follow-up.
